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NCT ID: NCT05937815 Recruiting - Cystic Fibrosis Clinical Trials

Intestine-lung Axis of Cystic Fibrosis Patients Treated With the Combination Elexacaftor/Tezacaftor/Ivacaftor

KAF-BIOTA
Start date: September 13, 2021
Phase: N/A
Study type: Interventional

Cystic fibrosis is a systemic disease, which affects in particular the respiratory and digestive systems of patients, sites of chronic inflammation. A new combination of elexacaftor/tezacaftor/ivacaftor has proven its efficacy for the treatment of patients aged 12 years and over with two F508del mutations or a so-called "minimal function" mutation associated with one F508del mutation. European marketing authorization was obtained in August 2020 and access in France should therefore arrive soon. Given that this treatment targets new mutations and that the efficacy seems greater than with LUM/IVA, it is important to assess its impact on the microbiota and the pulmonary and digestive inflammation of patients. It is therefore a question of taking advantage of the experience of the Lum-Iva-Biota cohort, and the validated and operational sample circuit established in the various participating centers to set up a biological collection for the collection and storage of sputum and stools of patients during the first year of treatment with elexacaftor/tezacaftor/ivacaftor, in order to study the effect of treatment on the lung and digestive microbiota/mycobiota and inflammation.

NCT ID: NCT05936710 Recruiting - Clinical trials for Intradialytic Hypotension

Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate

HEMODIACIDE
Start date: December 7, 2023
Phase: N/A
Study type: Interventional

During intermittent hemodialysis (IHD), the occurrence of intradialytic hemodynamic instability (IHI) is frequent in ICU and impacted morbidity and mortality. Bicarbonate dialysate buffer improves hemodynamic tolerance compared to acetate dialysate buffer. However, bicarbonate dialysate buffer still contains a lower concentration of acetate, which could contribute to hemodynamic instability. Recently, citrate-based dialysate in bicarbonate hemodialysis instead of acetate have been proposed. They have the appropriate authorizations for routine use. The aim of this study is to compare acetate- vs citrate-based dialysate in terms of hemodynamic tolerance and effectiveness.

NCT ID: NCT05936515 Recruiting - Iatrogenesis Clinical Trials

Evaluation of the Impact of a Paramedical Training Program for Nurses and Nursing Assistants on the Length of Stay and Prevention of Hospital Iatrogenic Complications in Elderly Patients

CORRESPAGE
Start date: May 1, 2023
Phase:
Study type: Observational

In France, hospitalised elderly patients (EP) aged >75 years are expected to represent 1/3 of patients by 2030 (22% in 2015). In acute care wards outside geriatrics, the average length of stay increases with age, i.e. 8.5 days after the age of 90 compared with 5.5 days for younger patients. Dependence related to hospitalisation, partly avoidable, occurs in 30 to 60% of patients aged over 70. Faced with this situation Geriatric Mobile Teams (GMT) were created in 2002 to meet the need for geriatric expertise in hospitals and in the community by making punctual evaluations. Expert and multidisciplinary, the GMTs are a referring team for "advice, information and training for health care teams" for the care of vulnerable EPs. The GMTs are dependent on an exclusively medical demand system. The lack of knowledge of a specific care for EPs by nurses and nursing assistants and the occasional contribution of GMTs prevents a systematic targeted a for EP. Over the past 30 years, an American nursing programme (NICHE) aimed at improving the overall care of EPs in hospitals has shown that the training of geriatric resource nurses in speciality wards brought about a significant change in hospital geriatric culture. The training is based on evidence based practice including the HELP programme targeting confusion. The HELP programme has shown that nurses and nursing assistants play a pivotal role in reducing the incidence of hospital confusion. In the USA, the implementation of NICHE begins with the creation of a team of nursing leaders (geriatric/education/clinical care experts), dedicated to the coordination of the training and the companionship of geriatric resource nurses. Within the framework of the targets of the Ségur de la santé 2020 and Ma Santé 2022, our hypothesis is that an adaptation of NICHE to the French health context could improve specific care for EP in specialist wards, reduce the occurrence of complications and reduce the length of stay. Indeed, the GMT would ensure this coordination role in the training and support of a nurse and nursing assistant duo, based on the model of hygiene correspondents, in order to disseminate good geriatric practices.

NCT ID: NCT05936359 Recruiting - Clinical trials for Myeloproliferative Neoplasms

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Start date: September 25, 2023
Phase: Phase 1
Study type: Interventional

This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.

NCT ID: NCT05936307 Recruiting - Clinical trials for Healthy Participants

Externalization and Stimulation

STUPEFIX
Start date: January 16, 2024
Phase: N/A
Study type: Interventional

The distinction between self-generated and external information is impaired in patients with schizophrenia, who are assumed to confuse imagination with real perceptions. To better understand the underlying mechanisms of these abnormalities, the investigator will investigate the brain mechanisms supporting auditory externalization. Auditory externalization is the ability to perceive whether a sound comes from inside or outside oneself. Our study, in healthy participants, will use functional brain imaging to identify the brain areas involved in the externalization of sound sources and to test whether neuromodulation of this area can modify this ability and provide a therapeutic lead in pathological populations

NCT ID: NCT05936073 Recruiting - Hepatitis D Clinical Trials

DELTA DESCRIBE: the French Collaborative Project

DELTADESCRIBE
Start date: March 1, 2023
Phase:
Study type: Observational

Our global objective is to draw up a photograph of HDV patients over one year in metropolitan France and identify the barriers of screening and care. The investigator suspects a mismatch between HBV and HDV screening, the first step for specialized care pathway in metropolitan France.

NCT ID: NCT05936034 Recruiting - Cancer Clinical Trials

Comparative Study of the Quality of Life of Patients Suffering From OTOTOXICITY Due to Chemotherapy Based on Platinum Salts Fitted With a Hearing Aid Compared to Those Not Fitted.

PROTOTOX
Start date: January 4, 2024
Phase: N/A
Study type: Interventional

There are many undesirable effects associated with platinum-based cancer treatments (renal failure, anaemia, etc.). Their administration also leads to neurosensory problems such as ototoxicity, tinnitus and reduced hearing acuity. According to a the French survey (2018), 39.7% of people suffer from hearing problems due to cancer treatments, five years after a cancer diagnosis. Improving side effects such as hypoacusis and tinnitus can significantly improve patients' quality of life and adherence to treatment. Many clinical trials proposed a medicinal solution to patients receiving platinum-based cancer treatments but none has led to a consensus on management. The aim of the study is to offer patients receiving platinum-based chemotherapy and suffering from hearing problems a hearing aid to improve their quality of life.

NCT ID: NCT05935995 Recruiting - Clinical trials for Squamous Cell Carcinoma of Head and Neck

Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination

HISTOBLOC
Start date: November 28, 2023
Phase: N/A
Study type: Interventional

Study to evaluate the use of confocal microscopy for detecting resection margins in patients undergoing surgery for basal cell carcinoma of skin and squamous Cell Carcinoma of Head and Neck

NCT ID: NCT05935228 Recruiting - Clinical trials for Peripheral Venous Access

Development and Evaluation of an Algorithm for Vascular Access Management

ALCOV
Start date: December 5, 2023
Phase: N/A
Study type: Interventional

Two billion catheters are placed annually worldwide. Of all the people requiring vascular access, nearly a quarter have Difficult Intravenous access (DIVA), a source of multiple punctures. The increased risk of haematomas, haemorrhages, infection, pain and associated trauma is responsible for increased human costs and economic impact. To limit the risks posed by the DIVA, practitioners have solutions such as the per-bone line, other types of lines, and placement of peripheral venous catheter with ultrasound or transluminescence. However, these solutions are not always applicable, depending on the care situation (non-substitutable venous access, fragile patient, etc.) or on the technical platform (available personnel and training, configuration of the premises, available equipment). Moreover, these actions are often taken after failures, in a non-anticipated and non-consensual manner. In order to assess the risk of DIVA, F.Van Loon et al developed in 2016, and then modified in 2018, a DIVA Scale (the A-DIVA Scale) which allows a rapid scoring upstream of peripheral venous catheter placement to classify patients according to the risk of DIVA. Composed of five items (non-palpable and non-visible vein, diameter < 3mm, history of DIVA, operator experience) worth one point each, the score allows three categories to be established: "low risk", "moderate risk", "high risk". The study showed that the proportion of first puncture failures increased with the risk of the patients (defined according to the categorized score). The use of a tool such as the A-DIVA Scale is of interest if it allows the definition of actions to be taken in relation to the risk it identifies. In view of this, it appears essential to optimize the management of peripheral venous catheters, particularly for patients with DIVAs. The aim of this study is to develop a graduate and specific response to the issue of multiple punctures. Our project is to create and evaluate a specific algorithm, consisting of a risk assessment (the A-DIVA Scale) and a co-construct decision-making tree (the A-DIVA Tool). Built on the basis of objective clinical data collection and adapted to the possibilities and competencies, this new tool would bring real benefits to the patient in terms of safety (reduction of risks) and comfort (reduction of pain and duration of management), as well as a medico-economic benefit for the institutions. To date, such an algorithm does not exist and its beneficial effects have not been evaluated.

NCT ID: NCT05935098 Recruiting - Solid Tumor Clinical Trials

A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors

Start date: August 21, 2023
Phase: Phase 1
Study type: Interventional

This study aims to test the safety, tolerability, and preliminary anti-tumor activity of BGB-A3055, either alone or in combination with Tislelizumab in participants with advanced or metastatic solid tumors.